Recruiting

Observational Study

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT05789901

Conditions

HIV Infections

Breast Cancer

Pediatric Emergency Medicine

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

Interventions

MARVIN

MARVIN-Pharma

MARVINA

MARVIN-CHAMP

Study Details

Brief summary:

This research is a continuation of a usability study with the MARVIN chatbot. The investigators aim to adapt the MARVIN chatbot to open it to other health domains (e.g. breast cancer) and populations (e.g. pharmacists). Therefore, this protocol constitutes a master research protocol that will englobe different research projects with individual chatbots. The investigators adopt an adaptive platform trial design, which will allow flexibility in handling multiple interventions adapted to different populations while retaining the characteristics of a platform trial design allowing early withdrawal of ineffective trial arms based on interim data (implementation outcomes) and introduction of new trial arms.

Conditions

HIV Infections

Breast Cancer

Pediatric Emergency Medicine

Study ID

NCT05789901

Start date

Mar 1, 2024

Status verified date

Mar, 2024

Completion date

Dec 31, 2034

Anticipated

Primary completion date

Dec 31, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

Inclusion Criteria for all objectives:

  • being 14 years or older;
  • being fluent in English and/or French;
  • being able to understand the requirements of study participation and provide informed consent during the duration of the study;
  • having access to a smartphone, tablet, or computer at home/at workplace;
  • having access to an internet connection at home or data plan on their device.

Inclusion Criteria Specific to objectives 2 and 3:

  • accept to use a Facebook Messenger-based Chatbot;
  • accept to use or create a personal Facebook account;
  • accept Facebook's privacy and data security policies.

Exclusion Criteria:

  • not meeting the inclusion criteria
  • any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving a chatbot (e.g., cognitive deficit)

Study Design

Enrollment

400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: MARVIN: a Chatbot for HIV patients

Co-construction of the chatbot, Usability study, Implementation, Evaluation of outcomes and Continuous improvements

other: MARVIN: a Chatbot for Community Pharmacists

Co-construction of the chatbots, Usability study, Implementation, Evaluation of outcomes and Continuous improvements

other: MARVINA: a Chatbot for Breast Cancer Patients

Co-construction of the chatbots, Usability study, Implementation, Evaluation of outcomes and Continuous improvements

other: MARVIN CHAMP: a Chatbot for Pediatric Infectious Conditions

Co-construction of the chatbots, Usability study, Implementation, Evaluation of outcomes and Continuous improvements

Interventions

MARVIN

Chatbot on Meta (Facebook) Messenger for HIV Patients

MARVIN-Pharma

Chatbot on Meta (Facebook) Messenger for community pharmacists

MARVINA

Chatbot on Meta (Facebook) Messenger for breast cancer patients

MARVIN-CHAMP

CHatbot to Assist the Management of Pediatric patients with infectious conditions (CHAMP)

Primary outcome measure

  • Usability Metric for User eXperience (UMUX-Lite) [ Time Frame: Immediately, after 1-month of testing - objective 2 ]
  • Acceptability E-Scale (AES) [ Time Frame: Immediately after 1-month of testing - objective 2 ]
  • Change in Acceptability E-Scale (AES) over 12 months [ Time Frame: Once every 3 months within 12 months ]
  • Change in Intervention Appropriateness Measure (IAM) over 12 months [ Time Frame: Once every 3 months within 12 months ]
  • Change in Compatibility Subscale over 12 months [ Time Frame: Once every 3 months within 12 months ]

Central Contacts and Locations

Central contacts

Bertrand Lebouché, MD

514-843-2090bertrand.lebouche@mcgill.ca

Locations

Centre hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montréal, Quebec, Canada, H2X 3E4

Contacts

Marie-Pacale Pomey, MD, PhD

514 890 8000marie-pascale.pomey@umontreal.ca

McGill University Health Centre (MUHC)

Recruiting

Montréal, Quebec, Canada, H4A 3J1

Contacts

Bertrand Lebouché, MD, PhD

5148432090bertrand.lecbouche@mcgill.ca

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Mar 6, 2024

Last verified

Mar, 2024

Keywords

  • Chatbot
  • Intelligent Conversational Agent
  • Co-Construction
  • Adherence
  • Antiretroviral Therapy
  • mHealth
  • Implementation Science
  • Care
  • Breast Cancer
  • HIV
  • Self-Management
  • Adaptive Platform Trial Design
  • Telehealth
  • Digital Health
  • Artificial Intelligence
  • Pediatric Emergency Medicine
  • Patient and Stakeholder Engagement
  • Pediatric Infection
  • Large Language Models

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2024-03-06.